Method, apparatus, and system for expression and quantification of human breast milk

ABSTRACT

Disclosed herein are devices, systems, and methods for the expression and collection of breast milk. A device in accordance with embodiments comprises an actuatable assembly and a breast interface configured to engage a breast and fluidly seal thereagainst. The breast interface comprises a movable member disposed within at least a portion of the breast interface. The device further comprises a tensile element operatively coupling the actuatable assembly to the movable member. Actuation of the actuatable assembly applies a tensile force to the tensile element, and the tensile element transmits the tensile force to the movable member to move the movable member away from the breast, thereby applying negative pressure to the breast to express milk therefrom.

CROSS-REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 14/221,113, filed on Mar. 20, 2014 [Attorney Docket No.44936-703.201], which claims the benefit of U.S. Provisional PatentApplication No. 61/804,722, filed on Mar. 24, 2013 [Attorney Docket No.44936-703.101] and U.S. Provisional Patent Application No. 61/879,055,filed on Sep. 17, 2013 [Attorney Docket No. 44936-703.102], the entirecontents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to medical devices and methods,and more particularly relates to devices and methods for expression andcollection of human breast milk.

The exemplary embodiments disclosed herein are preferably directed atexpression of breast milk, but one of skill in the art will appreciatethat this is not intended to be limiting and that the devices, systemsand methods disclosed herein may be used for other treatments requiringapplication of a differential pressure.

Breast pumps are commonly used to collect breast milk in order to allowmothers to continue breastfeeding while apart from their children.Currently, there are two primary types of breast pumps:manually-actuated devices, which are small, but inefficient and tiringto use; and electrically-powered devices, which are efficient, but largeand bulky. Therefore, it would be desirable to provide improved breastpumps that are small and highly efficient for expression and collectionof breast milk. Additional features such as milk productionquantification and communication with mobile devices are furtherdesirable for enhanced user convenience. At least some of theseobjectives will be satisfied by the devices and methods disclosed below.

2. Description of the Background Art

The following US patents are related to expression and collection ofhuman breast milk: U.S. Pat. Nos.: 6,673,036; 6,749,582; 6,840,918;6,887,210; 7,875,000; 8,118,772; and 8,216,179.

SUMMARY OF THE INVENTION

The present invention generally relates to medical devices and methods,and more particularly relates to devices and methods for expression andcollection of human breast milk.

In one aspect, a device for expression and collection of breast milkcomprises an actuatable assembly and a breast interface configured toengage a breast and fluidly seal thereagainst. The breast interfacecomprises a movable member disposed within at least a portion thereof.The de ice further comprises a tensile element operatively coupling theactuatable assembly to the movable member, wherein the tensile elementis disposed within an axial load absorbing member. Actuation of theactuatable assembly applies a tensile force to the tensile element,wherein the tensile element transmits the tensile force to the movablemember to move the movable member away from the breast, thereby applyingnegative pressure to the breast to express milk therefrom. The axialload absorbing member may be axially stiff to absorb reactive forces ofthe tensile element during application of the tensile force to thetensile element.

The tensile element may extend continuously between the movable memberand the actuatable assembly. The tensile element may comprise a cable,wire, or rope.

The axial load absorbing member may comprise a tube or coil having anaxially stiff geometry to absorb the reactive forces of the tensileelement.

The device may further comprise a tube extending between the breastinterface and the actuatable assembly, wherein the tensile element andthe axial load absorbing member may be disposed within the tube. Thetensile element may be concentrically disposed within the axial loadabsorbing member, and the axial load absorbing member may beconcentrically disposed within the tube.

The breast interface may further comprise an interface housing havingthe movable member disposed therein, and the actuatable assembly mayfurther comprise a driving element and an assembly housing having thedriving element disposed therein. The tensile element may comprise afirst end coupled to the movable member and a second end opposite thefirst end and coupled to the driving element. The axial load absorbingmember may comprise a first end coupled to the interface housing and asecond end opposite the first end and coupled to the assembly housing.

The device may further comprise a driving mechanism releasably coupledwith the actuatable assembly, and the actuatable assembly may comprise adriving element. Actuation of the driving mechanism may displace thedriving element from a rest position to move the movable member awayfrom the breast, or may replace the driving element to the rest positionto move the movable member toward the breast.

The movable member may comprise a deformable member configured tofluidly seal against the breast. The movable member may comprise aflexible membrane. The flexible membrane may comprise a corrugatedregion configured to expand and collapse.

In another aspect, a device for expression and collection of breast milkcomprises an actuatable assembly and a breast interface configured toengage a breast and fluidly seal thereagainst. The breast interfacecomprising a movable member disposed within at least a portion thereof.The device further comprises a tensile element operatively coupling theactuatable assembly to the movable member, the tensile element extendingcontinuously between the movable member and the actuatable assembly.Actuation of the actuatable assembly applies a tensile force to thetensile element, and the tensile element transmits the tensile force tothe movable member to move the movable member away from the breast,thereby applying negative pressure to the breast to express milktherefrom.

The tensile element may comprise a cable, wire, or rope.

The device may further comprise an axial load absorbing member, and thetensile element may be disposed within the axial load absorbing memberthat is axially stiff to absorb reactive forces of the tensile elementduring application of the tensile force to the tensile element. Theaxial load absorbing member may comprise a tube or coil having anaxially stiff geometry to absorb the reactive forces of the tensileelement. The device may further comprise a tube extending between thebreast interface and the actuatable assembly, wherein the tensileelement and the axial load absorbing member are disposed within thetube. The tensile element may be concentrically disposed within theaxial load absorbing member, and the axial load absorbing member may beconcentrically disposed within the tube.

The breast interface may further comprise an interface housing havingthe movable member disposed therein, and the actuatable assembly mayfurther comprise a driving element and an assembly housing having thedriving element disposed therein. The tensile element may comprise afirst end coupled to the movable member and a second end opposite thefirst end and coupled to the driving element. The axial load absorbingmember may comprise a first end coupled to the interface housing and asecond end opposite the first end and coupled to the assembly housing.

The device may further comprise a driving mechanism releasably coupledwith the actuatable assembly, wherein the actuatable assembly maycomprise a driving element. Actuation of the driving mechanism maydisplace the driving element from a rest position to move the movablemember away from the breast, or replace the driving element to the restposition to move the movable member toward the breast.

The movable member may comprise a deformable member. The movable membermay comprise a flexible membrane. The flexible membrane may comprise acorrugated region configured to expand and collapse.

Other objects and features of the present invention will become apparentby a review of the specification, claims, and appended figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a perspective view of an exemplary embodiment of a pumpingdevice.

FIG. 2 is a perspective view of an exemplary embodiment of a pumpingdevice.

FIG. 3 is a cross-section of an exemplary embodiment of a pumpingdevice.

FIG. 4 illustrates an exemplary embodiment of an actuatable assemblycoupled to a driving mechanism.

FIGS. 5A-5B illustrate an exemplary embodiment of an actuatable assemblycoupled to a pendant unit.

FIG. 6 is a cross-sectional view of an exemplary embodiment of a breastinterface.

FIG. 7 is a cross-sectional view of another exemplary embodiment of abreast interface.

FIG. 8A is a cross-sectional view of an exemplary embodiment of anintegrated valve in an open position.

FIG. 8B is a cross-sectional view of an exemplary embodiment of anintegrated valve in a closed position.

FIG. 9A is a cross-sectional view of an exemplary embodiment ofintegrated sensors within a breast interface.

FIG. 9B is a cross-sectional view of another exemplary embodiment ofintegrated sensors within a breast interface.

FIG. 10 illustrates an exemplary embodiment of a pendant unit and amobile device.

FIG. 11 illustrates an exemplary embodiment of a pendant unit incommunication with a mobile device.

FIG. 12 is a cross-sectional view of an exemplary embodiment of a breastinterface with a mechanical deformable member.

FIG. 13 is a cross-sectional view of an exemplary embodiment of amechanical driver for a mechanical deformable member.

FIG. 14 is a graph illustrating the pump performance of an exemplaryembodiment compared to a commercial device.

FIG. 15 is a graph illustrating the pumping efficiency of an exemplaryembodiment compared to a commercial device.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed devices and methods will now bedescribed with reference to the drawings. Nothing in this detaileddescription is intended to imply that any particular component, feature,or step is essential to the invention. One of skill in the art willappreciate that various features or steps may be substituted or combinedwith one another.

The present invention will be described in relation to the expressionand collection of breast milk. However, one of skill in the art willappreciate that this is not intended to be limiting, and the devices andmethods disclosed herein may be used in other applications involving thecreation and transmission of a pressure differential, such as in thetreatment of sleep apnea and/or other remote pressure needs.

FIG. 1 illustrates an exemplary embodiment of the present invention.Pumping device 100 includes breast interfaces 105, a tube 110, and acontroller or pendant unit 115 operatively coupled to breast interfaces105 through tube 110. Breast interfaces 105 include resilient andconformable flanges 120, for engaging and creating a fluid seal againstthe breasts, and collection vessels 125. The device may optionally onlyhave a single breast interface. Pendant unit 115 houses the power sourceand drive mechanism for pumping device 100, and also contains hardwarefor various functions, such as controlling pumping device 100, milkproduction quantification, and communication with other devices. Tube110 transmits suitable energy inputs, such as mechanical energy inputs,from pendant unit 115 over a long distance to breast interfaces 105.Breast interfaces 105 convert the energy inputs into vacuum pressureagainst the breasts in a highly efficient manner, resulting in theexpression of milk into collection vessels 125.

One of skill in the art will appreciate that components and features ofthis exemplary embodiment can be combined or substituted with componentsand features of any of the embodiments of the present invention asdescribed below. Similarly, components and features of other embodimentsdisclosed herein may be substituted or combined with one another.

Hydraulic Pumping Device

Hydraulic systems can reduce pumping force requirements, and thereforealso reduce the size of the pumping device, while maintaining highpumping efficiency. In a preferred embodiment, the pumping device canutilize a hydraulic or pneumatic pumping device to generate a pressuredifferential against the breast for the expression and collection ofmilk.

Exemplary hydraulic pumping devices are depicted in FIGS. 2 and 3. FIG.2 illustrates a pumping device 150 with a syringe 155 fluidly coupled tobreast interface 160 by tube 165. Syringe 155 is coupled to tube 165through a three-way valve 170. Breast interface 160 contains an exitport 175. The syringe 155 drives a fluid 180 contained within tube 165against or away from a flexible member contained within breast interface160 to create the pressure differential necessary for milk expressionfrom the breast.

FIG. 3 illustrates another embodiment of a pumping device 200. Theactuatable assembly 205 includes an assembly housing 210, a drivingelement 215, radial seals 220, and a shaft 222. Driving element 215 isoperatively coupled to a pendant unit, such as pendant unit 115, throughshaft 222. The tube 225 contains a fluid 230 and is fluidly coupled tothe actuatable assembly 205 and the breast interface 235. The breastinterface 235 consists of an interface housing 240, a flexible membrane245, a reservoir 250, a sealing element 255, an expression area 260, anda drain port 265. The sealing element 255 includes deformable portion270. The drain port 265 is coupled to a collection vessel 275 andincludes a flap valve 280.

Actuatable assembly 205 displaces fluid 230 contained within tube 225,which can be a flexible line. Fluid 230 occupies reservoir 250 withinbreast interface 235 and is coupled with flexible membrane 245. Flexiblemembrane 245 transmits vacuum pressure from fluid 230 to the deformableportion 270 of sealing element 255. When a breast is engaged into andfluidly sealed with breast interface 235 by sealing element 255,displacement of the actuatable element 215 produces substantial vacuumpressure against the breast through flexible membrane 245 and deformableportion 270, resulting in the expression of breast milk into expressionarea 260. The expressed milk drains through drain port 265 intocollection vessel 275. Drain port 265 is configured with a flap valve280 to provide passage of milk while maintaining vacuum pressure inexpression area 260.

The fluid for the hydraulic pumping device can be any suitable fluid,such as an incompressible fluid. In many embodiments, the incompressiblefluid can be water or oil. Alternatively, the fluid can be any suitablegas, such as air. Suitable incompressible fluids and gases for hydraulicsystems are known to those of skill in the art.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the hydraulic pumping device can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Actuation Mechanism

Many actuation mechanisms known to those of skill in the art can beutilized for the actuatable assembly 205. Actuatable assembly 205 can bea piston assembly, a pump such as a diaphragm pump, or any othersuitable actuation mechanism. The optimal configuration for actuatableassembly 205 can depend on a number of factors, such as: vacuumrequirements; size, power, and other needs of the pumping device 200;and the properties of the fluid 230, such as viscosity,biocompatibility, and fluid life requirements.

FIG. 3 illustrates an exemplary embodiment in which actuatable assembly205 is a piston assembly and driving element 215 is a piston. Actuatableassembly 205 includes radial seals 220, such as O-rings, sealing againstassembly housing 210 to prevent undesired egress of fluid 230 and toenable driving of fluid 230.

FIG. 4 illustrates another exemplary embodiment of an actuatableassembly 300 including a pair of pistons 305.

In preferred embodiments, the actuatable assembly includes a drivingelement powered by a suitable driving mechanism, such as a drivingmechanism residing in pendant unit 115. Many driving mechanisms areknown to those of skill in the art. For instance, the driving element,such as driving element 215, may be actuated electromechanically by amotor, or manually by a suitable user-operated interface, such as alever. Various drive modalities known to those of skill in the art canbe used. In particular, implementation of the exemplary hydraulicpumping devices as described herein enables the use of suitable drivemodalities such as direct drive and solenoids, owing to the reducedforce requirements of hydraulic systems.

Referring now to the exemplary embodiment of FIG. 4, the pistons 305include couplings 310 to a crankshaft 315. The crankshaft 315 isoperatively coupled to a motor 320 through a belt drive 325. Thecrankshaft 315 drives the pair of pistons 305 with the same stroketiming in order to apply vacuum pressure against both breastssimultaneously, a feature desirable for increased milk production.Alternatively, the crankshaft 315 can drive the pair of pistons 305 withany suitable stroke timing, such as alternating or offset stroke cycles.

The driving mechanism can be powered by any suitable power source, suchas a local battery or an AC adaptor. The driving mechanism can becontrolled by hardware, such as onboard electronics located withinpendant unit 115.

FIG. 5 illustrates an exemplary embodiment of an actuatable assembly 350that includes releasable coupling 355. Preferably, actuatable assembly350 is releasably coupled to a pendant unit 360 and the drivingmechanism housed therein. The coupling can be a mechanical coupling orany suitable quick release mechanism known to those of skill in the art.The releasably coupled design allows for flexibility in theconfiguration and use of the pumping device. For instance, user comfortcan be improved through the use of differently sized breast interfacesfor compatibility with various breast sizes. Additionally, this featureenables a common pumping device to be used with interchangeable breastinterfaces, thus reducing the risk of spreading pathogens. Furthermore,the releasable coupling enables easy replacement of individual parts ofthe pumping device.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the actuation mechanism can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Flexible Membrane

In many embodiments such as the embodiment depicted in FIG. 3, theflexible membrane 245 is located within breast interface 235 anddisposed over at least portion thereof, forming reservoir 250 betweenthe interface housing 240 and the flexible membrane 245. Preferably, theflexible membrane 245 deforms substantially when subject to the negativepressures created when the fluid 230 is displaced from reservoir 250 byactuatable assembly 205. The amount of deformation of the flexiblemembrane 245 can be controlled by many factors, (e.g., wall thickness,durometer, surface area) and can be optimized based on the pumpingdevice (e.g., pump power, vacuum requirements).

FIG. 6 illustrates an exemplary flexible membrane 370 with a specifiedthickness and durometer.

FIG. 7 illustrates another embodiment of flexible membrane 375 withcorrugated features 380 for increased surface area.

Suitable materials for the flexible membrane are known to those of skillin the art. In many embodiments, the flexible membrane can be made of amaterial designed to expand and contract when subject to pressures fromthe coupling fluid such as silicone, polyether block amides such asPEBAX, and polychloroprenes such as neoprene. Alternatively, theflexible membrane can be fabricated from a substantially rigid material,such as stainless steel, nitinol, high durometer polymer, or highdurometer elastomer. In these embodiments, the rigid material would bedesigned with stress and/or strain distribution elements to enable thesubstantial deformation of the flexible membrane without surpassing theyield point of the material.

FIGS. 8A and 8B illustrate preferred embodiments of a breast interface400 in which an exit valve 405 is integrated into the flexible membrane410 to control the flow of expressed milk through exit port 415. Theexit valve 405 is opened to allow fluid flow when the flexible membrane410 is relaxed, as shown in FIG. 8A, and is closed to prevent fluid flowwhen the flexible membrane 410 is deformed, as shown in FIG. 8B. Theexit valve 405 enables substantial vacuum pressure to be present inexpression area 420 during extraction, while allowing milk to drainduring the rest phase of the pump stroke. While many conventional breastpump valves function on pressure differentials alone, the exit valve 405can preferably be configured to also function on the mechanical movementof flexible membrane 410. Incorporation of an integrated exit valve 405with mechanical functionality as described herein can improve thesealing of the breast interface 400 during vacuum creation. Furthermore,the implementation of an exit valve integrally formed within theflexible membrane 410 such as exit valve 405 reduces the number of partsto be cleaned.

Milk Collection and Quantification System

With reference to FIG. 3, expressed milk drains through exit port 265 inflexible membrane 245 into a collection vessel 275. Collection vessel275 can be any suitable container, such as a bottle or a bag. In manyembodiments, collection vessel 275 is removably coupled to flexiblemembrane 245. Collection vessel 275 can be coupled directly or remotelyvia any suitable device such as extension tubing.

In many instances, it can be desirable to track various data related tomilk expression and collection, such as the amount of milk production.Currently, the tracking of milk production is commonly accomplished bymanual measurements and record-keeping. Exemplary embodiments of thedevice described herein may provide digital-based means to automaticallymeasure and track milk production for improved convenience, efficiency,and accuracy.

FIGS. 9A and 9B illustrates exemplary embodiments of a breast interface450 with one or more integrated sensors 455. Sensors 455 are preferablylocated in flap valve 460, but may also be located in exit valve 465, orany other suitable location for monitoring fluid flow. In a preferredembodiment, at least one sensor 455 is integrated into a valve that isopened by fluid flow and detects the length of time that the valve isopened. The sensor signal can be interrogated to quantify the fluidflow. Suitable sensors are known to those of skill in the art, such asaccelerometers, Hall effect sensors, and photodiode/LED sensors. Thebreast interface can include a single sensor or multiple sensors toquantify milk production.

FIG. 10 illustrates an exemplary embodiment of pendant unit 500 in whichmilk expression data is shown on a display screen 505. In manyembodiments, the pendant unit 500 collects, processes, stores, anddisplays data related to milk expression. Preferably, the pendant unit500 can transmit the data to a second device, such as a mobile phone510.

FIG. 11 illustrates data transmission 515 between pendant unit 500 and amobile phone 510. Suitable methods for communication and datatransmission between devices are known to those of skill in the art,such as Bluetooth or near field communication.

In exemplary embodiments, the pendant unit 500 communicates with amobile phone 510 to transmit milk expression data, such as expressionvolume, duration, and date. The mobile phone 510 includes a mobileapplication to collect and aggregate the expression data and display itin an interactive format. Preferably, the mobile application includesadditional features that allow the user to overlay information such aslifestyle choices, diet, and strategies for increasing milk production,in order to facilitate the comparison of such information with milkproduction statistics. Additionally, the pendant unit 500 can sendinformation about the times of pump usage to the mobile phone 510 sothat the mobile application can identify when pumping has occurred andset reminders at desired pumping times. Such reminders can help avoidmissed pumping sessions, and thus reduce the incidence of associatedcomplications such as mastitis.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the milk collection andquantification system can be combined or substituted with components andfeatures of any of the embodiments of the present invention as describedherein.

Mechanical Pumping Device

FIG. 12 illustrates an alternative embodiment of a breast interface 600in which a mechanical deformable member 605 can be used in place of aflexible membrane. The mechanical deformable member 605 can beconstructed from similar techniques as those used for the flexiblemembrane as described herein. The mechanical deformable member 605 iscoupled to a tensile element 610. In some instances, tensile element 610is disposed within an axial load absorbing member 615. The axial loadabsorbing member 615 is disposed within tube 620. Preferably, tensileelement 610 is concentrically disposed within axial load absorbingmember 615 and axial load absorbing member 615 is concentricallydisposed within tube 620. Alternative arrangements of tensile element610, axial load absorbing member 615, and tube 620 can also be used.

FIG. 13 illustrates the tensile element 610 coupled to driving element625 of an actuatable assembly 630 within an assembly housing 635.Driving element 625 is operatively coupled to a driving mechanism, suchas a driving mechanism housed within a pendant unit, through shaft 640.Axial load absorbing member 615 within tube 620 is fixedly coupled tothe assembly housing 635. Displacement of the driving element 625transmits tensile force through tensile element 610 to the mechanicaldeforming member 605 to create vacuum pressure against the breast.

The tensile element 610 can be any suitable device, such as a wire,coil, or rope, and can be made from any suitable material, such asmetals, polymers, or elastomers. Axial load absorbing member 615 can bemade from any suitable axially stiff materials, such as metals orpolymers, and can be configured into any suitable axially stiffgeometry, such as a tube or coil.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the mechanical pumping device can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Experimental Data

FIGS. 14 and 15 illustrate experimental pumping data obtained from acommercial breast pump device and an exemplary embodiment of the presentinvention. The exemplary embodiment utilized an incompressible fluid forpumping and had a maximum hydraulic fluid volume of 4 cc, while thecommercial device utilized air for pumping and had a maximum volume of114 cc.

FIG. 14 illustrates a graph of the pump performance as quantified byvacuum pressure generated per run. For the exemplary embodiment,pressure measurements were taken for 1 cc, 2 cc, 3 cc, and 4 cc of fluidvolume displaced by the pump, with the run number corresponding to thevolume in cc. For the commercial device, measurements were taken withthe pump set to one of seven equally incremented positions along thevacuum adjustment gauge representing 46 cc, 57 cc, 68 cc, 80 cc, 91 cc,103 cc, and 114 cc of fluid volume displaced by the pump, respectively,with the run number corresponding to the position number. Curve 700corresponds to the exemplary embodiment and curve 705 corresponds to thecommercial device. The exemplary embodiment generated higher levels ofvacuum pressure per displacement volume compared to the commercialdevice, with maximum vacuum pressures of −240.5 mmHg and −177.9 mmHg,respectively.

FIG. 15 illustrates a graph of the pump efficiency as measured by themaximum vacuum pressure per maximum volume of fluid displaced, with bar710 corresponding to the exemplary embodiment and bar 715 correspondingto the commercial device. The exemplary embodiment demonstrated a42-fold increase in pumping efficiency compared to the commercialdevice, with efficiencies of −71.1 mmHg/cc and −1.7 mmHg/cc,respectively.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A device for expression and collection of breastmilk, said device comprising: an actuatable assembly; a breast interfaceconfigured to engage a breast and fluidly seal thereagainst, the breastinterface comprising a movable member disposed within at least a portionthereof; and a tensile element operatively coupling the actuatableassembly to the movable member, wherein the tensile element is disposedwithin an axial load absorbing member, wherein actuation of theactuatable assembly applies a tensile force to the tensile element, andwherein the tensile element transmits the tensile force to the movablemember to move the movable member away from the breast, thereby applyingnegative pressure to the breast to express milk therefrom, and whereinthe axial load absorbing member is axially stiff to absorb reactiveforces of the tensile element during application of the tensile force tothe tensile element.
 2. The device of claim 1, wherein the tensileelement extends continuously between the movable member and theactuatable assembly.
 3. The device of claim 1, wherein the tensileelement comprises a cable, wire, or rope.
 4. The device of claim 1,wherein the axial load absorbing member comprises a tube or coil havingan axially stiff geometry to absorb the reactive forces of the tensileelement.
 5. The device of claim 1, wherein the device further comprisesa tube extending between the breast interface and the actuatableassembly, and wherein the tensile element and the axial load absorbingmember are disposed within the tube.
 6. The device of claim 5, whereinthe tensile element is concentrically disposed within the axial loadabsorbing member, and wherein the axial load absorbing member isconcentrically disposed within the tube.
 7. The device of claim 1,wherein the breast interface further comprises an interface housinghaving the movable member disposed therein, and the actuatable assemblyfurther comprises a driving element and an assembly housing having thedriving element disposed therein, wherein the tensile element comprisesa first end coupled to the movable member and a second end opposite thefirst end and coupled to the driving element, and wherein the axial loadabsorbing member comprises a first end coupled to the interface housingand a second end opposite the first end and coupled to the assemblyhousing.
 8. The device of claim 1, further comprising a drivingmechanism releasably coupled with the actuatable assembly, wherein theactuatable assembly comprises a driving element, and wherein actuationof the driving mechanism displaces the driving element from a restposition to move the movable member away from the breast or replaces thedriving element to the rest position to move the movable member towardthe breast.
 9. The device of claim 1, wherein the movable membercomprises a deformable member configured to fluidly seal against thebreast.
 10. The device of claim 9, wherein the movable member comprisesa flexible membrane.
 11. The device of claim 10, wherein the flexiblemembrane comprises a corrugated region configured to expand andcollapse.
 12. A device for expression and collection of breast milk,said device comprising: an actuatable assembly; a breast interfaceconfigured to engage a breast and fluidly seal thereagainst, the breastinterface comprising a movable member disposed within at least a portionthereof; and a tensile element operatively coupling the actuatableassembly to the movable member, the tensile element extendingcontinuously between the movable member and the actuatable assembly,wherein actuation of the actuatable assembly applies a tensile force tothe tensile element, and wherein the tensile element transmits thetensile force to the movable member to move the movable member away fromthe breast, thereby applying negative pressure to the breast to expressmilk therefrom.
 13. The device of claim 12, wherein the tensile elementcomprises a cable, wire, or rope.
 14. The device of claim 12, whereinthe device further comprises an axial load absorbing member, and whereinthe tensile element is disposed within the axial load absorbing memberthat is axially stiff to absorb reactive forces of the tensile elementduring application of the tensile force to the tensile element.
 15. Thedevice of claim 14, wherein the axial load absorbing member comprises atube or coil having an axially stiff geometry to absorb the reactiveforces of the tensile element.
 16. The device of claim 14, wherein thedevice further comprises a tube extending between the breast interfaceand the actuatable assembly, and wherein the tensile element and theaxial load absorbing member are disposed within the tube.
 17. The deviceof claim 16, wherein the tensile element is concentrically disposedwithin the axial load absorbing member, and wherein the axial loadabsorbing member is concentrically disposed within the tube.
 18. Thedevice of claim 14, wherein the breast interface further comprises aninterface housing having the movable member disposed therein, and theactuatable assembly further comprises a driving element and an assemblyhousing having the driving element disposed therein, wherein the tensileelement comprises a first end coupled to the movable member and a secondend opposite the first end and coupled to the driving element, andwherein the axial load absorbing member comprises a first end coupled tothe interface housing and a second end opposite the first end andcoupled to the assembly housing.
 19. The device of claim 12, furthercomprising a driving mechanism releasably coupled with the actuatableassembly, wherein the actuatable assembly comprises a driving element,and wherein actuation of the driving mechanism displaces the drivingelement from a rest position to move the movable member away from thebreast or replaces the driving element to the rest position to move themovable member toward the breast.
 20. The device of claim 12, whereinthe movable member comprises a deformable member.
 21. The device ofclaim 20, wherein the movable member comprises a flexible membrane. 22.The device of claim 21, wherein the flexible membrane comprises acorrugated region configured to expand and collapse.